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Advertising Medical Devices In the US
Under Federal Food, Drug, And Cosmetic Act (FFDCA)
Medical Devices are to be sold only for FDA cleared (510k) or approved (PMA)
Intended Uses. If a device is promoted for an indication other than what was
approved they risk being charged with adulteration or misbranding. This
enforcement policy also applies to devices that are sold with false or
misleading claims, and counterfeits.
FEDERAL TORT CLAIMS ACT (FTCA)
Deceptive advertising is also equally enforced under The Federal Tort Claims Act
(FTCA) who prohibit false advertising – misleading in a material respect. While
the FDA is mainly concerned with the labeling of devices, the FTC requires that
advertising be truthful – with substantiated objective claims – and not be
misleading.
Unlike the FDA who participate and regulate preapproval claims, the FTC are
primarily responsible for postmarket claims. Civil liability can be brought upon
individuals or the organization – especially where the infringement was done
knowingly (or with disregard for the truth).
FDA REQUIREMENTS
If your device is a PMA device FDA must approve the labeling, unlike 510k
cleared devices. However, 510k devices still require that you submit an
“Indications for Use” statement at the time of submission. This has prompted
some manufacturers to construct their Indications for Use statement in a general
manner in the hope of covering a wider use category in the event of forthcoming
changes. Note that this practice has it’s pitfalls because unless you specify
the use in the official statement given to the FDA – they will consider that
your device does NOT follow it’s clearance. This is true also for submissions
where substantiating data was provided in the submission.
The FDA also states that changes in the “Indications for Use” requires
resubmission of your 510k or in the case of PMA, a manufacturer is required to
submit a PMA supplement.
INTERNET LABELING
Under 21 CFR 801.4 the FDA look at all circumstances surrounding distribution
when determining intended use of devices. There have been cases where warning
letters have alleged that the manufacturer promoted “off-label” uses of their
devices (on the Internet).
Many challenges that manufacturers have therefore, result where particular
clearances have been given for different foreign countries. These websites
however can be accessed from the United States and hence present the
manufacturer with the dilemma of posting their information.
The best way to post information on the Internet is to:
Provide separate links to the different regulatory regions (countries) – then
present the information that is relevant to that country, AND
Indicate US regulatory status of the device (in the event a visitor [from US]
accidentally lands on the webpage)
HOW DOES THE FDA ENFORCE ADVERTISING OF DEVICES?
The FDA probably do not have employees actively seeking misbranding of devices.
That is to say they do not have them do this full time. However, there are many
ways the FDA learns about adulteration and misbranding.
The biggest single source of information tips probably originates with your
competitors. By their nature the FDA will seek out the truth and may investigate
the claim. Other “informants” include employees who are concerned that the new
indications may cause harm, as well as disgruntled ones who only want to get
back at management (or stand to profit by participating as “whistleblowers”).
The incredible monetary rewards that result from whistleblower cases has
prompted a pseudo-vigilant watchdog over the device and pharmaceutical industry.
THE CONSEQUENCES OF PROMOTING OFF LABEL USES
The risks that your organization faces for the mislabeling/promotion of devices
are substantial. Criminal charges can and have been brought before executive
managers, including: CEOs, Regulatory Affairs Managers (VPs), Legal and Sales
personnel.
The monetary fines that can be given are again incredible with manufacturers
being ask to pay in the hundreds of millions. The fines are given on a per false
claim basis and have been as high as $11000 per instance. Whistleblowers who
testify against the organization are ‘rewarded’ up to 30% of the eventual
recovery – which can earn them tens of millions to the hundreds of millions of
dollars!
Ultimately, prosecution against an organization can have dire consequences as a
result of a negative reputation. Stock prices have been know to nose dive as a
result of criminal proceedings. Restoring consumer confidence once the damage
has been done can be an enormous undertaking.
CONCLUSION
With FDA/FTC regulating the advertising field it makes good sense to be careful
when dispensing advertising material. Most large firms have entire legal and
regulatory affairs departments review all advertising material for approval.
With the risks involved and the ever changing complexity of advertising media it
is better to be cautious than to be wrong.
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